Alltest SARS-Covid-2 Rapid Antigen Test Kit Nasal Swab Single Test
TGA Reference: INCP-502H
The SARS-CoV-2 Antigen Rapid Test (Nasal Swab) is a single-use test kit intended to detect the SARS-CoV-2 that causes COVID-19 with self-collected nasal swab specimen from symptomatic individuals who are suspected of being infected with COVID-19 within the first 7 days of symptom onset. Results are for the detection of SARS-CoV-2 Nucleocapsid protein Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results are indicative of the presence of SARS-CoV-2. Individuals who test positive should self-isolate and seek additional care from their healthcare provider. Positive results do not rule out bacterial infection or co-infection with other viruses. Negative results do not preclude SARS-CoV-2 infection. Individuals who test negative and continue to experience COVID-like symptoms should seek follow up care from their healthcare provider. The SARS-CoV-2 Antigen Rapid Test (Nasal Swab) is intended to be used by laypersons as a self-test for home and workplace (in offices, for sporting events, airports, schools, etc.).
For further information visit the TGA listing found here
Materials Provided
• Test cassette
• Package insert
• Sterile swab
• Extraction buffer
• Biosafety bag
Materials required but not provided
• Timing device
Please read all the information in this package insert before performing the test.
• For self-testing in vitro diagnostic use only. Do not use after expiration date.
• Do not eat, drink or smoke in the area where the specimens or kits are handled.
• Do not drink the buffer in the kit. Carefully handle the buffer and avoid it contacting
skin or eyes, rinse with plenty of running water immediately if contacting.
• Store in a dry place at 2-30 °C (36-86 °F), avoiding areas of excess moisture. If the foil
packaging is damaged or has been opened, please do not use.
• This test kit is intended to be used as a preliminary test only and repeatedly abnormal
results should be discussed with doctor or medical professional.
• Follow the indicated time strictly.
• Use the test only once. Do not dismantle and touch the test window of the test cassette.
• The kit must not be frozen or used after the expiration date printed on the package.
• Keep out of the reach of children.
• Test for children and young people should be used with an adult.
• Do not use the test on children under 2 years old.
• Small children should be swabbed with the help of a second adult.
• Wash hands thoroughly before and after handling.
• Please ensure that an appropriate amount of samples are used for testing. Too much or
too little sample size may lead to deviation of results.
LIMITATIONS
1. Performance was evaluated with nasal swab specimens only, using the procedures
provided in this package insert.
2. The SARS-CoV-2 Antigen Rapid Test (Nasal Swab) will only indicate the presence of
SARS-CoV-2 antigens in the specimen.
3. If the test result is negative or non-reactive and clinical symptoms persist, it is because
the very early infection virus may not be detected, It is recommended to test again with
a new kit or test with a molecular diagnostic device to rule out infection in these
individuals.
4. Negative results do not rule out SARS-CoV-2 infection, particularly in those who have
been in contact with the virus. Follow-up testing with a molecular diagnostic should be
considered to rule out infection in these individuals.
5. Positive results of COVID-19 may be due to infection with non- SARS-CoV-2
coronavirus strains or other interference factors.
6. Failure to follow these procedures may alter test performance.
7. False negative results may occur if a specimen is improperly collected or handled.
8. False negative results may occur if inadequate levels of viruses are present in the
specimen.
9. The SARS-CoV-2 Antigen Rapid Test (Nasal Swab) is less reliable in the later phase of
infection, it is recommended to use the test within the first 7 days of symptom onset.